FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K003038 |
AGILENT TECHNOLOGIES DEUTSCHLAND GMBH |
AGILENT COMPONENT MONITORING SYSTEM, AGILENT V24/26, AGILENT BIS MODULE, MODEL M1175A/76A/77A,REV.L,M1205A,REV.L,M1034A |
12/15/2000 |
K010965 |
ALARIS MEDICAL SYSTEMS, INC. |
A-LINE AEP MONITOR |
06/27/2001 |
K963644 |
ASPECT MEDICAL SYSTEMS, INC. |
A-1000 EEG MONITOR AND A-1050 EEG MONITOR |
10/08/1996 |
K974496 |
ASPECT MEDICAL SYSTEMS, INC. |
A-2000 EEG MONITOR WITH BIS |
02/06/1998 |
K062613 |
ASPECT MEDICAL SYSTEMS, INC. |
BIS EEG MONITOR VIEW |
06/18/2007 |
K052362 |
ASPECT MEDICAL SYSTEMS, INC. |
BIS EEG MONITOR, MODEL A-3000 |
09/09/2005 |
K052981 |
ASPECT MEDICAL SYSTEMS, INC. |
BIS EEG MONITOR, MODEL BISX4 |
11/01/2005 |
K072286 |
ASPECT MEDICAL SYSTEMS, INC. |
BIS EEG VISTA MONITOR SYSTEM AND BISX |
11/20/2007 |
K002837 |
ASPECT MEDICAL SYSTEMS, INC. |
BIS ENGINE |
09/19/2000 |
K011834 |
ASPECT MEDICAL SYSTEMS, INC. |
BIS ENGINE |
07/10/2001 |
K040183 |
ASPECT MEDICAL SYSTEMS, INC. |
BISX |
02/25/2004 |
K011534 |
ASPECT MEDICAL SYSTEMS, INC. |
EEG MIS MONITOR MODEL # A-2000; BIS ENGINE |
06/15/2001 |
K030267 |
ASPECT MEDICAL SYSTEMS, INC. |
EEG MONITOR WITH BIS, MODEL A-2000 |
01/15/2004 |
K031694 |
ASPECT MEDICAL SYSTEMS, INC. |
MODIFICATION TO EEG MONITOR WITH BIS, MODEL A-2000 |
08/29/2003 |
K213273 |
Cortical Dynamics Ltd |
Brain Anesthesia Response Monitor (Bar Monitor) |
09/01/2023 |
K042315 |
DANMETER A/S |
CEREBRAL STATE MONITOR - CSM |
01/21/2005 |
K013389 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 BIS MODULE, M-BIS AND ACCESSORIES |
01/10/2002 |
K023459 |
DATEX-OHMEDA |
DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES |
01/13/2003 |
K060997 |
EVEREST BIOMEDICAL INSTRUMENTS CO. |
SNAP II EEG MONITOR |
06/15/2006 |
K052145 |
GE HEALTHCARE |
DATEX-OHMEDA S/5 BIS MODULE, E-BIS AND ACCESSORIES |
08/23/2005 |
K050835 |
GE HEALTHCARE |
DATEX-OHMEDA S/5TM ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
05/06/2005 |
K061907 |
GE HEALTHCARE |
MODIFICATION TO: DATEX-OHMEDA S/5 ENTROPY MODULE, E-ENTROPY AND ACCESSORIES |
03/27/2008 |
K150298 |
GE HEALTHCARE FILAND OY |
Entropy Module, E-ENTROPY-01 |
11/12/2015 |
K012466 |
GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN |
BIS/EEG MODULE |
10/01/2001 |
K203113 |
Masimo Corporation |
Masimo SedLine Sedation Monitor and Accessories |
02/25/2022 |
K172890 |
Masimo Corporation |
SedLine Sedation Monitor |
01/26/2018 |
K083063 |
MENNEN MEDICAL LTD. |
BIS INTERFACE FOR VITALOGIK PATIENT MONITORS |
12/16/2008 |
K071899 |
MENNEN MEDICAL LTD. |
BIS MODULE FOR ENVOY PATIENT MONITOR |
10/22/2007 |
K033543 |
MT MONITORTECHNIK GMBH & CO. KG |
NARCOTREND, MODEL COMPACT 4.0 |
09/17/2004 |
K202621 |
NeuroWave Systems Inc. |
NeuroSENSE Monitoring System, Model NS-901 |
08/05/2021 |
K020218 |
NICOLET BIOMEDICAL, INC. |
SNAP EEG MONITOR |
04/22/2002 |
K001069 |
PHYSIOMETRIX, INC. |
MODEL 4000 EEG MONITOR WITH PSI (PSA4000) |
06/30/2000 |
K020671 |
PHYSIOMETRIX, INC. |
PSA4000 EEG MONITOR WITH FRONTAL PSI |
10/04/2002 |
K051874 |
PHYSIOMETRIX, INC. |
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET |
09/02/2005 |
K033999 |
PHYSIOMETRIX, INC. |
SEDLINE WITH FRONTAL PSI |
02/06/2004 |
K060900 |
SPACELABS MEDICAL INC. |
SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91482 AND ACCESSORIES MODEL-91842 |
06/23/2006 |
K973596 |
SPACELABS MEDICAL, INC. |
SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODULE |
02/03/1998 |